crossover randomized trial
NCT05227196
A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Semaglutide 14 mg oral once daily (original tablet) Group 1 first generation oral semaglutide 14 mg | lifestyle: not reported | 222 | 169 | |
| A2 | Semaglutide 9 mg oral once daily (reformulated tablet) Group 1 second generation oral semaglutide 9 mg | lifestyle: not reported | 222 | 169 | |
| A3 | Semaglutide 7 mg oral once daily (original tablet) Group 2 first generation oral semaglutide 7 mg | lifestyle: not reported | 201 | 113 | |
| A4 | Semaglutide 4 mg oral once daily (reformulated tablet) Group 2 second generation oral semaglutide 4 mg | lifestyle: not reported | 201 | 113 | |
| A5 | Semaglutide 3 mg oral once daily (original tablet) Group 3 first generation oral semaglutide 3 mg | lifestyle: not reported | 123 | 111 | |
| A6 | Semaglutide 1.5 mg oral once daily (reformulated tablet) Group 3 second generation oral semaglutide 1.5 mg | lifestyle: not reported | 123 | 111 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Semaglutide 14 mg oral once daily (original tablet) A1 | Semaglutide 9 mg oral once daily (reformulated tablet) A2 | Semaglutide 7 mg oral once daily (original tablet) A3 | Semaglutide 4 mg oral once daily (reformulated tablet) A4 | Semaglutide 3 mg oral once daily (original tablet) A5 | Semaglutide 1.5 mg oral once daily (reformulated tablet) A6 |
|---|---|---|---|---|---|---|---|
| age | mean (years) | 39.6 | 39.6 | 42.4 | 42.4 | 40.4 | 40.4 |
| age | sd (years) | 11.9 | 11.9 | 11.3 | 11.3 | 11.8 | 11.8 |
| asian | n | 4 | 4 | 6 | 6 | 10 | 10 |
| asian | percent | 2.4 | 2.4 | 5.3 | 5.3 | 9.0 | 9.0 |
| black | n | 70 | 70 | 26 | 26 | 29 | 29 |
| black | percent | 41.4 | 41.4 | 23.0 | 23.0 | 26.1 | 26.1 |
| bmi | mean (kg/m2) | 27.1 | 27.1 | 26.3 | 26.3 | 26.7 | 26.7 |
| bmi | sd (kg/m2) | 3.1 | 3.1 | 2.6 | 2.6 | 3.1 | 3.1 |
| female | n | 76 | 76 | 56 | 56 | 55 | 55 |
| female | percent | 45.0 | 45.0 | 49.6 | 49.6 | 49.5 | 49.5 |
| hispanic | n | 20 | 20 | 28 | 28 | 33 | 33 |
| hispanic | percent | 11.8 | 11.8 | 24.8 | 24.8 | 29.7 | 29.7 |
| other race american indian alaska native | n | 3 | 3 | 0 | 0 | 0 | 0 |
| other race american indian alaska native | percent | 1.8 | 1.8 | ||||
| other race native hawaiian pacific islander | n | 0 | 0 | 0 | 0 | 1 | 1 |
| other race native hawaiian pacific islander | percent | 0.9 | 0.9 | ||||
| other race other | n | 2 | 2 | 0 | 0 | 8 | 8 |
| other race other | percent | 1.2 | 1.2 | 7.2 | 7.2 | ||
| weight | mean (kg) | 79.1 | 79.1 | 76.2 | 76.2 | 76.9 | 76.9 |
| weight | sd (kg) | 12.8 | 12.8 | 11.3 | 11.3 | 12.0 | 12.0 |
| white | n | 90 | 90 | 81 | 81 | 63 | 63 |
| white | percent | 53.3 | 53.3 | 71.7 | 71.7 | 56.8 | 56.8 |
Results
30 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Serious adverse events (6 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 213 | not stated; safety; R0013595:Table 4 | ||||
| A2 | events | 2 / 210 | not stated; safety; R0013595:Table 4 | ||||
| A3 | events | 0 / 193 | not stated; safety; R0013595:Table 5 | ||||
| A4 | events | 1 / 195 | not stated; safety; R0013595:Table 5 | ||||
| A5 | events | 0 / 122 | not stated; safety; R0013595:Table 6 | ||||
| A6 | events | 0 / 120 | not stated; safety; R0013595:Table 6 |
Discontinuation due to adverse events (6 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 11 / 213 | not stated; safety; R0013595:Table 4 | ||||
| A2 | events | 4 / 210 | not stated; safety; R0013595:Table 4 | ||||
| A3 | events | 1 / 193 | not stated; safety; R0013595:Table 5 | ||||
| A4 | events | 5 / 195 | not stated; safety; R0013595:Table 5 | ||||
| A5 | events | 0 / 122 | not stated; safety; R0013595:Table 6 | ||||
| A6 | events | 1 / 120 | not stated; safety; R0013595:Table 6 |
Nausea (6 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 65 / 213 | not stated; safety; R0013595:Table 4 | ||||
| A2 | events | 62 / 210 | not stated; safety; R0013595:Table 4 | ||||
| A3 | events | 53 / 193 | not stated; safety; R0013595:Table 5 | ||||
| A4 | events | 46 / 195 | not stated; safety; R0013595:Table 5 | ||||
| A5 | events | 12 / 122 | not stated; safety; R0013595:Table 6 | ||||
| A6 | events | 13 / 120 | not stated; safety; R0013595:Table 6 |
Vomiting (2 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 51 / 213 | not stated; safety; R0013595:Table 4 | ||||
| A2 | events | 42 / 210 | not stated; safety; R0013595:Table 4 |
Diarrhea (4 lines; O27C)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 26 / 213 | not stated; safety; R0013595:Table 4 | ||||
| A2 | events | 22 / 210 | not stated; safety; R0013595:Table 4 | ||||
| A3 | events | 22 / 193 | not stated; safety; R0013595:Table 5 | ||||
| A4 | events | 19 / 195 | not stated; safety; R0013595:Table 5 |
Death by suicide (6 lines; O35B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 1 / 213 | not stated; safety; R0013595:Results | ||||
| A2 | events | 0 / 210 | not stated; safety; R0013595:Results | ||||
| A3 | events | 0 / 193 | not stated; safety; R0013595:Supplement Table S3 | ||||
| A4 | events | 0 / 195 | not stated; safety; R0013595:Supplement Table S3 | ||||
| A5 | events | 0 / 122 | not stated; safety; R0013595:Table 6 | ||||
| A6 | events | 0 / 120 | not stated; safety; R0013595:Table 6 |